Certified Rare Disease Pharmacist (CRDP)

CRDP (RDP-001) Exam Objectives

This exam certifies that the candidate possesses the specialized clinical, logistical, and advocacy skills required to provide comprehensive pharmaceutical care to patients with rare diseases.

Domain 1: Rare Disease Pathophysiology and Therapeutics (35%)

• Disease State Knowledge: For key rare diseases (e.g., cystic fibrosis, Huntington's disease, muscular dystrophies, lysosomal storage diseases), describe the underlying pathophysiology and clinical presentation.
• Orphan Drug Management: For a given orphan drug, describe its mechanism of action, place in therapy, appropriate dosing, monitoring parameters, and management of significant adverse effects.
• Evidence Evaluation: Critically assess the limited evidence from small clinical trials and real-world data to make informed therapeutic recommendations.

Domain 2: Patient-Centered Care Coordination (30%)

• Holistic Patient Assessment: Given a patient case, identify the full spectrum of patient needs beyond the prescription, including psychosocial support, adherence challenges, and educational gaps.
• Multidisciplinary Care Planning: Develop a care plan that involves communication and coordination with the patient's entire healthcare team (e.g., specialists, primary care, home health).
• Patient Education and Counseling: Provide effective education to patients and caregivers on their disease state, complex medication regimens, and self-management techniques.

Domain 3: Access, Reimbursement, and Logistics (25%)

• Prior Authorization and Appeals: Construct a comprehensive prior authorization request for a high-cost orphan drug, including a letter of medical necessity. Outline the steps in the appeals process.
• Financial Assistance Navigation: Identify and utilize various resources to reduce patient out-of-pocket costs, including manufacturer patient assistance programs (PAPs), co-pay cards, and foundation support.
• Limited Distribution Drug (LDD) Management: Describe the unique procurement, handling, and data reporting requirements associated with LDDs.

Domain 4: Patient Advocacy and Support (10%)

• Resource Connection: Connect patients and families with relevant patient advocacy groups, support networks, and community resources.
• Legislative Knowledge: Explain the significance of the Orphan Drug Act of 1983 and its impact on the development of therapies for rare diseases.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CRDP Professionals

The CRDP is a critical certification for pharmacists working in specialty pharmacy, either independently or within a health system or PBM. It is also highly relevant for those working directly for pharmaceutical manufacturers in patient support or clinical liaison roles.

Target Candidates

• Specialty pharmacists at health systems, PBMs, or independent pharmacies.
• Pharmacists working for pharmaceutical manufacturers in patient support or medical affairs.
• Clinical pharmacists at designated Centers of Excellence for rare diseases.
• Pharmacists with a strong interest in genetics, specialty drugs, and patient advocacy.

Primary Job Roles:

• Specialty Pharmacist / Clinical Care Coordinator
• Pharmacist at a designated Center of Excellence for a rare disease
• Patient Access Specialist
• Clinical or Medical Science Liaison for a biopharmaceutical company
• Managed Care Case Manager for rare diseases

Career Advancement:

A CRDP is positioned for leadership within a specialty pharmacy or health system, managing a team of pharmacists and technicians dedicated to rare diseases. They can advance to become a Director of Clinical Services or a Director of a specialty pharmacy. Their expertise is also valuable in strategic roles helping manufacturers design patient support programs and market access strategies.

Study Resources

Prepare for your CRDP exam with a range of study materials designed to help you succeed.